(63 days)
Not Found
No
The device description and performance studies focus on mechanical components and structural integrity, with no mention of AI or ML technologies.
Yes
The device is intended for the "treatment of cranial, midface, or mandibular conditions" and "to provide temporary stabilization and gradual lengthening of the cranial, midfacial, or mandibular bones," which clearly indicates a therapeutic purpose.
No
The device is described as a "distraction system" for "temporary stabilization and gradual lengthening" of bones, intended for "treatment of cranial, midface, or mandibular conditions." This indicates a therapeutic, rather than diagnostic, function.
No
The device description explicitly lists physical components such as a distractor frame, plates, machine screws, flexible shaft, and distraction key, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "treatment of cranial, midface, or mandibular conditions" and provides "temporary stabilization and gradual lengthening of the cranial, midfacial, or mandibular bones." This describes a therapeutic intervention performed on the patient, not a test performed on a sample taken from the patient.
- Device Description: The description details a mechanical system (distractor frame, plates, screws, etc.) used to physically manipulate bone. This is consistent with a surgical or therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening
In summary, the device is a surgical/therapeutic device used for bone distraction, not a diagnostic test performed in vitro.
N/A
Intended Use / Indications for Use
This product is intended for use in the treatment of cranial, midface, or mandibular conditions for which reconstructive oscotomy and segment are indicated. This includes conditions such as, syndromic cramosynostosis, midfacial cetrusion, hemifacial microsomia, und mandibular micrognathia. The device is mended to provide temporary stabilization and gradual lengthening of the cranial, midfacial, or mandibular bones
Product codes
JEY
Device Description
This device is a distraction system consisting of the following major components; distractor frame, plates, machine screws, flexible shaft, and distraction key. The plates and frame initially stabilize and then gradually distract the osteotomy. The flexible shaft, covered with a protective sheath, is connected to the frame and provides the point of attachment for the key used to initiate the distraction of the osteotomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial, midface, mandibular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Static cantilever bend testing was conducted on the Cohen Distractor and two currently available and legally marketed distraction devices, the Vazquez-Diner Distractor and the MULTI-GUIDE™ distractor (a.k.a. the Howmedica Mandibular Bone Distractor II). The results of the testing demonstrated that the Cohen Distractor had a significantly greater frame stiffness compared to the MULTI-GUIDE™ and Vazquez-Diner devices. The Cohen Distractor had an average yield strength which was significantly greater than the average yield strength of the MULTI-GUIDE™ device, and was slightly lower than the Vazquez-Diner device. It is not anticipated that this difference will have any relevance in the clinical setting because of the low forces observed in patients who are treated with all of these devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K964649, K960297, K# Unknown, K950595, K953806
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.
0
510(k) SUMMARY
| Device Proprietary Name: | Cohen Distractor |
|---|---|
| Device Common Name: | Bone Distractor |
| Classification Name: | Smooth or Threaded Metallic Bone Fixation |
| Fastener 21 CFR 888.3040 | |
| Name of Submitter: | Howmedica Leibinger Inc. |
| Contact Person: | John F. Dichiara |
| Group Manger of Regulatory Affairs | |
| Howmedica Leibinger Inc. | |
| 359 Veterans Blvd | |
| Rutherford, NJ 07070 | |
| Telephone: | 201-507-7836 |
| Fax: | 201-507-6870 |
| Date Prepared: | 6/5/97 |
Summary:
This submission describes a bone distraction system intended for use in the treatment of cranial, midfacial, or mandibular conditions for which reconstructive osteotomy and segment advancement are indicated. This includes conditions such as, syndromic craniosynostosis, midfacial retrusion, hemifacial microsomia, and mandibular micrognathia. The device is intended to provide temporary stabilization and gradual lengthening of the cranial, midfacial, or mandibular bones. This device is a distraction system consisting of the following major components; distractor frame, plates, machine screws, flexible shaft, and distraction key. The plates and frame initially stabilize and then gradually distract the osteotomy. The flexible shaft, covered with a protective sheath, is connected to the frame and provides the point of attachment for the key used to initiate the distraction of the osteotomy.
Static cantilever bend testing was conducted on the Cohen Distractor and two currently available and legally marketed distraction devices, the Vazquez-Diner Distractor and the MULTI-GUIDE™ distractor (a.k.a. the Howmedica Mandibular Bone Distractor II). The results of the testing demonstrated that the Cohen Distractor had a significantly greater frame stiffness compared to the MULTI-GUIDE™ and Vazquez-Diner devices. The Cohen Distractor had an average yield strength which was significantly greater than the average yield strength of the MULTI-GUIDE™ device, and was slightly lower than the Vazquez-Diner device. It is not anticipated that this difference will have any relevance in the clinical setting because of the low forces observed in patients who are treated with all of these devices.
Equivalence for this device is based on similarities in intended use, material, design and operational principle to the Vazquez - Diner Intraoral Distractor (Howmedica Leibinger K964649); the Mandibular Bone Distractor II (Howmedica K960297); the Normed Distractor (Ace Surgical Supply [US Distributor] K # Unknown); the Lubr Small Fixation Plating System (Howmedica K950595) and the Synthes Midface Plating System (Synthes) K953806.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. John F. Dichiara Group Regulatory Affairs Manager Howmedica, Inc. Pfizer Hospital Products Group 359 Veterans Boulevard Rutherford, New Jersey 07070-2584
AUG 1 1 1997
- Re: K972154 K972166 Trade Names: Cohen Distractor Guerrero-Bell Distractor Regulatory Class: II Product Code: JEY Dated: June 6, 1997 Received: June 9, 1997
Dear Mr. Dichiara:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the devices, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification
2
Page 2 - Mr. John F. Dichiara
submissions does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
[signature]
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
ludications for Use
长972154 STO(k) Number (if Known)
Device Name
I cibinger Cohen Distractor
Indications for Use
This product is intended for use in the treatment of cranial, midface, or mandibular conditions for which reconstructive oscotomy and segment are indicated. This includes conditions such as, syndromic cramosynostosis, midfacial cetrusion, hemifacial microsomia, und mandibular micrognathia. The device is mended to provide temporary stabilization and gradual lengthening of the cranial, midfacial, or mandibular bones
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANDITHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
K
Prescription Lise
(Per 21 CFR 801 109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
collid